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Also known as fluoxetine, Prozac, Fluoxetine Hydrochloride, Sarafem
LY110140 · 6 trials · 3 indications
C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.
HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.
Relapse defined as meeting any of these criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with a Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalized for depression or suicidality; Discontinued due to lack of efficacy/worsening of depression/suicidality. MADRS is a 10-item rating scale for depressive mood symptoms severity, items rated on 0-6 scale, with total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at discretion of investigator based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were "censored" at their last observation.
CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\*visit, age category\*visit and baseline\*visit.
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| Fluoxetine | EXPERIMENTAL | Flexible dosing of 20 to 40 milligrams (mg) administered orally, once daily, for approximately 52 weeks |
| 20 mg Fluoxetine | EXPERIMENTAL | 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks |
| 40 mg Fluoxetine | EXPERIMENTAL | 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo (capsules) administered orally, once daily, for 6 weeks |
| Olanzapine and Fluoxetine combination (OFC) | EXPERIMENTAL | - |
| Duloxetine 60 mg | EXPERIMENTAL | - |
| Duloxetine 30 mg | EXPERIMENTAL | - |
| 5 milligrams (mg) LY110140 (SD) | EXPERIMENTAL | 5 mg administered once in the fasted state on Day 1 |
| 20 mg LY110140 (SD) | EXPERIMENTAL | 20 mg administered once in the fasted state on Day 1 |
| 40 mg LY110140 (SD) | EXPERIMENTAL | 40 mg administered once in the fasted state on Day 1 |
| Placebo (MD) | PLACEBO_COMPARATOR | Placebo once daily oral dosing for 28 consecutive days |
| 20 mg LY110140 (MD) | EXPERIMENTAL | 20 mg once daily oral dosing for 28 consecutive days |
| 40 mg LY110140 (MD) | EXPERIMENTAL | 40 mg once daily oral dosing for 28 consecutive days |
| Name | Type | Description |
|---|---|---|
| Fluoxetine | DRUG | Administered orally |
| Placebo | DRUG | - |
| Olanzapine and Fluoxetine combination (OFC) | DRUG | Open label acute phase: introductory dose for 4 days then 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks. Open label stabilization phase: 6/25, 12/25, 6/50, 12/50 or 18/50 mg, oral, daily for 16-20 weeks. Double blind relapse prevention phase: dose determined during stabilization phase at Week 17, oral, daily, for 27 weeks. |
| duloxetine | DRUG | 60 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase) |
| Olanzapine | DRUG | - |
| LY110140 | DRUG | Administered orally as capsules |
Inclusion Criteria: * Have completed Study B1Y-JE-HCLV (NCT#:NCT01808612) * Agree to abstain from sexual activity or to use a reliable method of birth control Exclusion Criteria: * Significant suicidal risk * Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizoph...
LY110140 is an investigational small molecule developed by Eli Lilly and Company. It has been studied in a Phase 1 clinical trial in healthy Japanese male participants. The specific disease or condition it is intended to treat has not been publicly disclosed, and the compound remains in early clinical development.
LY110140 is made by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the developer and sponsor of the clinical program for this investigational small molecule.
LY110140 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
LY110140 has been evaluated in one completed Phase 1 trial, NCT01569126, titled A Study of LY110140 in Healthy Japanese Male Participants. The trial enrolled 56 healthy male volunteers in Japan, was randomized, double-blind, and placebo-controlled, and included participants aged 20 years and older.
No. LY110140 is an investigational small molecule in Phase 1 clinical development and has not been approved by the FDA. Its only listed trial, NCT01569126, has been completed, and no active trials are currently reported for the compound.